MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D133602

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Ischemic Heart Disease (2493)

Event Date 12/20/2022

Event Type  Injury  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a male patient underwent a cryo afib, svt, & typical flutter ablation procedure with a thermocool® smart touch¿ electrophysiology catheter.The patient suffered cardiac arrest and electrocardiogram st segment elevation.It was reported that the carto 3 system displayed a chest patch sensor error (error code 1007) in the middle of performing ablation on the cavotricuspid ishmus (cti) line.They stated that chest patch 6 was displayed on the carto 3 system as moving/jumping all over the place.They lost the respiratory graph on the carto 3 system.They confirmed that the chest patch cable was fully connected to the electrodes and the patch unit and the issue persisted.They did not perform any further troubleshooting due to the patient's loss of pulse.Replacement chest patch cable requested.The field service engineer will be dispatched for the unresolved issue and part order.Software version confirmed 7.2 (full code unknown) it was also reported that a minute or 2 minutes after the chest patch issue occurred, the patient lost their pulse.There was inferior st elevation on the ecgs displayed on the carto 3 system.They reported that the patient had a drop in blood pressure.Cpr was performed by the nurses and doctors and the patient's pulse was restored.They analyzed the coronary arteries and that "everything looked good at that point." they were unsure if the patient was in stable condition.The physician believed that the injury occurred due to a reaction to protamine or that there may have been air in the coronary arteries.They reported that the procedure was aborted and that 3/4 of the procedure was completed.The catheter box was discarded after the case.It was an f curve unidirectional thermocool smart touch ablator.The adverse event was discovered after use of our products.Physician¿s opinion on the cause of this adverse event was the patient condition or procedure -- thought it was a protamine reaction or air in the coronaries.Intervention provided was cpr.Outcome of the adverse event was improved, blood pressure returned to normal, and pulse returned.It is unknown if the patient required extended hospitalization because of the adverse event.Relevant tests/laboratory data-unknown.Other relevant history- unknown.Carto serial number ¿ (b)(4).Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16181765
• MDR Text Key: 307482490
• Report Number: 2029046-2023-00101
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: 10846835009002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D133602
• Device Catalogue Number: D133602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Male